The proposed project will test in a limited number of rural and semi-rural sites in the state of Kansas an innovative model of synchronous ("live") Internet initiation and intensification of once- daily basal insulin glargine in type 2 diabetic patients that can be deployed statewide in a subsequent larger study (R18). The study's specific aims are to 1) develop a synchronous ("live") interactive Internet-administered course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self- adjust the dose to achieve a HbA1c d 7.0% using a treat-to-target algorithm;and 2) to assess for the Internet patients selected clinical and psychometric outcomes. These will include HbA1c, frequency and severity of hypoglycemia, psychological resistance to insulin treatment, diabetes quality of life, and treatment satisfaction. The study builds upon the findings of the Treat-to-Target and INITIATE trials, as well as on successful Internet interventions for weight management, and both lays the conceptual foundation and gathers the expertise to successfully apply for the R18, which will have as primary aims addressing of delays to insulin therapy documented in the DAWN study and cost- effectiveness analysis of the Internet intervention.
Aim 1 represents development of a "proof of concept" model of the innovation that can form the basis for the R18.
Aim 2 will allow us to estimate the effect size needed for power calculations for the R18 designed to identify statistically significant parameters of effectiveness of and treatment satisfaction with Internet-initiation and intensification as compared to practice-based initiation and to estimate the potential for statewide deployment of the innovation, as well as its potential for reducing critical delays to insulin treatment. The pilot hopes to show that Internet teaching of basal insulin therapy is comparable to traditional insulin management with respect to safety and effectiveness as measured against expected (published) results for frequency of hypoglycemia and percent of patients reaching target. Psychometric outcomes are exploratory - and hypothesis generating with respect to the subsequent R18 application.
The proposed pilot project will test the safety and effectiveness of a synchronous (live), interactive Internet intervention for initiating Type 2 diabetic patients on once-daily basal insulin using a treat-to-target algorithm and, to our knowledge, is the first trial designed to conduct group insulin initiation and intensification in a synchronous and highly interactive Internet environment. Initiating insulin is a particularly time-consuming process for time- and resource-constrained primary care providers and, in a largely rural state such as Kansas, patients often have to drive 60 miles to see a diabetes educator - or 300 miles to see a diabetes specialist. Thus, the proposed project addresses critical access barriers to insulin therapy and has the potential for reducing complications associated with the disease, as well as lessening cost burden to patient, provider, and the State.